Effects of Ultrasound-guided Maxillary Nerve Block Performed After Bimaxillary Osteotomy in Adult Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorServei Central d'Anestesiologia

About this trial

Bimaxillary osteotomy is a surgery procedure of the orthognathic surgery field for correction of dental and facial abnormalities, for both functional and aesthetic cases. The incidence of this abnormality is 5-10% of the population, and the etiology is unknown, with genetic, environmental and embryonic factors related. The surgery technic is complex, and requires osteotomy of the maxilla and jaw, which allows toward, forward, impact and rotation of these bones to fix the edges of the face. The anesthetic management of these patients is a challenge because of the difficult airway management and the perioperative pain control. Multimodal approach for pain control is a fact, and the use of local and regional anaesthesia is mandatory. The investigators propose bilateral ultrasound-guided suprazigomatic maxillary nerve block after bimaxillary osteotomy for a proper control of postoperative pain.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients undergoing scheduled bimaxillary surgery

Disqualifiers

refusal to participate in the study

patients scheduled for bimaxillary surgery together with another complementary surgical procedure (such as rhinoplasty, blepharoplasty)

age < 18 years

reinterventions

Trial design

Design model

Parallel

Treatments tested in this trial

  • Maxillary nerve block

    Procedure/Surgery

    Ultrasound-guided, suprazygomatic approach, infrazygomatic window

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Maxillary nerve block before bimaxillary osteotomyActive comparator 1 intervention
Group B: Maxillary nerve block after bimaxillary osteotomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Inmediate Postoperative pain

Postoperative pain in patients undergoing elective bimaxillary osteotomy, evaluated using the visual analog pain scale in the immediate postoperative period (2 hours postoperative). VAS: Visual analogue scale (0=minimum pain - 10=maximum pain)

Time frame
2 hours postoperatively

Secondary outcomes

1

Pain at 8 hours postoperatively

Pain in patients undergoing elective bimaxillary osteotomy, evaluated using the visual analog pain scale at 8 hours postoperatively. VAS: Visual analogue scale (0=minimum pain - 10=maximum pain)

Time frame
8 hours postoperatively
2

Pain 18 hours after surgery

Pain in patients undergoing elective bimaxillary osteotomy, evaluated using the visual analog pain scale at 18 hours postoperatively. VAS: Visual analogue scale (0=minimum pain - 10=maximum pain)

Time frame
18 hours postoperatively
3

Inmediate Use of Opioids

Use of rescue opioids (milligrams of methadone) in the immediate postoperative period in resuscitation ward (milligrams of intravenous methadone at 2 hours postoperatively)

Time frame
2 hours postoperatively
4

Use of rescue opioids from 2 to 18 hours postoperatively

Use of rescue oipoids in the hospitalization ward (milligrams of subcutaneous methadone from 2 to 18 hours postoperatively)

Time frame
2 to 18 hours postoperatively

Other outcomes

Sponsors and contacts

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